5mg, 10 mg Film-coated tablets
prasugrel
What Prasugrel Mylan is and what it is used for
Prasugrel Mylan, which contains the active substance prasugrel, belongs to a group of medicines called platelet inhibitors. Platelets are very small cells in the blood. When a blood vessel is damaged, for example in cuts, the platelets clump together to form a blood clot ( clot ). Therefore, platelets are necessary to stop bleeding. If blood clots form in an atherosclerotic blood vessel, such as an artery, they can become very dangerous because they can shut off the blood supply and cause a heart attack (heart attack), stroke, or death. Blood clots in the arteries (blood vessels) that supply the heart with blood can also reduce blood supply and cause unstable angina(angina).
Prasugrel Mylan prevents platelets from clumping together, reducing the risk of blood clots forming.
You have been given Prasugrel Mylan because you have already had a heart attack or have unstable angina and have been treated with a method that opens clogged arteries in your heart. You may also have one or more stents inserted to keep open a blocked or narrowed artery that supplies blood to the heart. Prasugrel Mylan reduces the risk of you having another heart attack or stroke or dying from a blood clot in your blood vessels. Your doctor has also prescribed you take acetylsalicylic acid, which is another antiplatelet agent.
What you need to know before you take Prasugrel Mylan
Do not take Prasugrel Mylan if you
- is allergic to prasugrel or any of the other ingredients of this medicine (listed in section 6). An allergic reaction manifests itself as a rash on the skin, itching, swelling of the face or lips, or shortness of breath. If this has happened to you, contact your doctor immediately.
- have any disease that causes bleeding such as bleeding from the stomach or intestines.
- ever had a stroke or transient ischemic attack ( TIA ).
- have severe liver disease.
Warnings and cautions
- Before you take Prasugrel Mylan:
Talk to your doctor before taking Prasugrel Mylan.
Tell your doctor before taking Prasugrel Mylan if any of the following apply to you:
- if you have an increased risk of bleeding for example:
- is 75 years or older. Your doctor should prescribe a daily dose of 5 mg as the risk of bleeding is greater in patients over 75 years of age.
- a recent, serious injury.
- recently undergone surgery (including some dental procedures).
- recent or recurrent bleeding from the stomach or intestine (eg gastric ulcer, polyps in the colon) body weight of less than 60 kg. Your doctor will prescribe a daily dose of 5 mg of Prasugrel Mylan if you weigh less than 60 kg.
- kidney disease or liver problems that are not considered serious.
- taking certain types of medicines (see “Taking other medicines” below).
- planned surgery (including certain dental procedures) within the next seven days. Your doctor may want you to stop taking Prasugrel Mylan temporarily due to the risk of bleeding.
- if you have had allergic reactions (hypersensitivity) to clopidogrel or any other antiplatelet agent, you should tell your doctor before starting treatment with Prasugrel Mylan. If you are taking Prasugrel and experience allergic reactions such as rash, itching, swollen face, swollen lips, or difficulty breathing, you should inform your doctor immediately.
- When you take Prasugrel Mylan:
You should inform your doctor immediately if you get a disease called thrombotic thrombocytopenic purpura (or TTP) which causes fever and bleeding under the skin that manifests as red pin-sized dots, with or without unexplained extreme fatigue, confusion, yellowing of the skin, or eyes ( jaundice) (see section 4 Possible side effects ).
Children and young people
Prasugrel Mylan must not be used by children or adolescents under 18 years of age.
Other medicines and Prasugrel Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, dietary supplements, and herbal medicines. It is especially important to tell your doctor if you are being treated with:
- clopidogrel (an antiplatelet agent)
- warfarin ( anticoagulant )
- non-steroidal anti-inflammatory drugs for pain and fever (such as ibuprofen, naproxen, etoricoxib).
Taking these medicines together with Prasugrel Mylan may increase the risk of bleeding.
Tell your doctor if you are taking morphine or other opioids (to treat severe pain).
Only take such medicines with Prasugrel Mylan that your doctor has told you to use.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Tell your doctor if you become pregnant or are trying to become pregnant while taking Prasugrel Mylan. You should use Prasugrel Mylan only after discussing with your doctor the possible benefits for you and any risks to the fetus.
If you are breastfeeding, talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
Prasugrel Mylan is unlikely to affect your ability to drive or use machines.
Prasugrel Mylan 5 mg contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essential ‘sodium-free’.
Prasugrel Mylan 10 mg contains para-orange FCF aluminum lake (E110) and sodium
Para-orange FCF aluminum lake (E110) is a dye, which can cause allergic reactions. This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essential ‘sodium-free’.
How to take Prasugrel Mylan
Always take Prasugrel Mylan exactly as your doctor has told you. You should consult your doctor or pharmacist if you are not sure.
The usual dose of prasugrel is 10 mg once a day. You will start treatment with a single dose of 60 mg. If you weigh less than 60 mg or are older than 75 years, the dose is one 5 mg Prasugrel Mylan per day. Your doctor will also tell you to take acetylsalicylic acid and how much to take (usually between 75 mg and 325 mg daily).
You can take Prasugrel Mylan regardless of the meal. Take dose one at about the same time each day. Do not break or crush the tablets.
It is important to tell your doctor, dentist, and pharmacist that you are taking Prasugrel Mylan.
If you take more Prasugrel Mylan than you should
Contact your doctor or hospital immediately, as there is a risk of severe bleeding. Show your doctor the package of Prasugrel Mylan.
If you forget to take Prasugrel Mylan
If you forget to take your daily dose, take Prasugrel Mylan when you can. If you have not remembered to take Prasugrel Mylan for the whole day, then just take the usual dose the next day. Do not take two doses on the same day.
If you stop taking Prasugrel Mylan
Do not stop treatment with Prasugrel Mylan without consulting your doctor, if you stop taking Prasugrel Mylan too soon, the risk of having a heart attack is greater.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you notice any of the following:
- Sudden numbness or weakness in the arm, leg, or face, especially if only one side of the body is affected
- Sudden confusion, difficulty speaking or understanding others
- Sudden difficulty walking or keeping balance or coordination difficulties
- Sudden dizziness or sudden severe headache for no known reason
All of the above reactions may be signs of a stroke. Stroke is a less common side effect of Prasugrel Mylan in patients who have never had a stroke or transient ischemic attack ( TIA ).
You should also contact your doctor immediately if you notice any of the following:
- Fever and bleeding under the skin that appears as red pin-sized dots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 2 “What you need to know before taking Prasugrel Mylan”)
- Rash, itching, or swollen face, swollen lips, swollen tongue, or difficulty breathing. This may be a sign of a severe allergic reaction (see section 2 “What you need to know before taking Prasugrel Mylan”)
Tell your doctor as soon as possible if you notice any of the following:
- Blood in the urine
- Bleeding from the rectum, blood in the stool, or black stools
- Bleeding that can not be stopped, for example, from a cut
All of the above reactions may be signs of bleeding which is the most common side effect of Prasugrel Mylan. Severe bleeding can be life-threatening but is less common.
Common side effects (may affect up to 1 in 10 people)
- Bleeding from the stomach or intestines
- Bleeding from the insertion site of the needle
- Nosebleed
- Rash
- Small red bruises on the skin ( ecchymosis )
- Blood in the urine
- Bleeding under the skin at an injection site, or in a muscle that causes swelling (hematoma)
- Low hemoglobin or red blood cell count ( anemia )
- Bruises.
Uncommon side effects (may affect up to 1 in 100 people)
- Allergic reactions (rash, itching, swollen lips/tongue or difficulty breathing)
- Spontaneous bleeding from the eye, rectum, gums, or abdomen around the internal organs
- Bleeding after surgery
- Bloody cough
- Blood in stool.
Rare side effects (may affect up to 1 in 1,000 people)
- Low red blood cell count
- Bleeding under the skin causes swelling ( subcutaneous hematoma).
How to store Prasugrel Mylan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the can and the carton after “EXP”. The expiration date is the last day of the specified month.
Prasugrel Mylan 5 mg: Do not store above 30 ° C. Store in the original package Moisture sensitive.
Prasugrel Mylan 10 mg: Do not store above 25 ° C. Store in the original package Moisture sensitive.
Blister pack only: Do not store above 30 ° C. Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is prasugrel.
Prasugrel Mylan 5 mg: Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel.
Prasugrel Mylan 10 mg: Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel.
- Other ingredients are:
Prasugrel Mylan 5 mg: microcrystalline cellulose, mannitol, crospovidone, colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), glyceryl monocaprylocaprate, sodium lauryl sulfate, yellow iron oxide (E172).
Prasugrel Mylan 10 mg: microcrystalline cellulose, mannitol, crospovidone, colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), glyceryl monocaprylocaprate, sodium lauryl sulfate, yellow iron oxide (E172), para-orange E1010F “Prasugrel Mylan 10 mg contains para-orange FCF aluminum lake”), red iron oxide (E172).
What the medicine looks like and the contents of the pack
Prasugrel Mylan 10 mg film-coated tablets are beige film-coated, capsule-shaped, biconvex tablets measuring 11.15 mm × 5.15 mm, marked with “PH4” on one side of the tablet and with “M” on the other side.
This medicine is available in plastic cans containing desiccant and 28 or 30 film-coated tablets, in blister packs containing 28, 30, 84, 90, 98 film-coated tablets, and in perforated blister packs containing 30 × 1 and 90 × 1 film-coated tablets.
Prasugrel Mylan 5 mg film-coated tablets are yellow film-coated, capsule-shaped, biconvex tablets measuring 8.15 mm × 4.15 mm, marked with “PH3” on one side of the tablet and with “M” on the other side.
This medicine is available in plastic cans containing a desiccant and 28 or 30 film-coated tablets, as well as in blister packs containing 28, 30, 84, or 98 film-coated tablets.
Do not eat or remove the desiccant contained in the jar
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
Manufacturer
Mylan Hungary Kft
Mylan utca 1, Komárom, 2900, Hungary
McDermott Laboratories Limited t / a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange State, Dublin 13, Ireland